Why it was recalled
CGMP Deviations: Shipment of product not approved for release.
Product description
Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Lot numbers, UPCs & expiration codes
Lot 16-836-FW, Exp 04/14
Where it was sold
NC
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-215-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 21, 2012
- FDA report date
- Apr 3, 2013
- Quantity
- 1,296 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira, Inc.
Original FDA data
Every field from FDA enforcement report D-215-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 63242
- Address
- 600 N Field Dr Bldg J45
- Code information
- Lot 16-836-FW, Exp 04/14
- Postal code
- 60045
- Report date
- Apr 3, 2013
- Product type
- Drugs
- Recall number
- D-215-2013
- Classification
- Class III
- Recalling firm
- Hospira, Inc.
- Product quantity
- 1,296 units
- Termination date
- Mar 28, 2013
- Reason for recall
- CGMP Deviations: Shipment of product not approved for release.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
- Distribution pattern
- NC
- Recall initiation date
- Jun 21, 2012
- Initial firm notification
- Telephone
- Center classification date
- Mar 22, 2013